FDA Registration Active 🇨🇳 China

MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2,MX2 BW Diagnostic Ultrasound System

Reg #: 3009156722 · FEI: 3009156722 · Expires 2025
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3

Registration Details

Registration Name
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Registration Number
3009156722
FEI Number
3009156722
Status
Active
Expiry Year
2025
Initial Importer
No
Address
1203 Nanhuan Avenue, Guangming District
City
Shenzhen Guangdong
Country
CN

Regulatory Submissions

510(k) Number
K250110

Owner / Operator

Firm Name
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Operator Number
9058402
Address
MINDRAY BUILDING,KEJI 12TH RD., SOUTH, HI-TECH INDUSTRIAL PARK
City
NANSHAN, SHENZHEN, GUANGDONG
State
CN-GD
Postal Code
518057
Country
CN

US Agent

Business Name
Mindray DS USA, Inc
Contact Name
James Clifford
Address
800 MacArthur Blvd
City
Mahwah
State
NJ
ZIP
07430
Country
US
Phone
201 6709353

Products

Device Name Product Code
System, Imaging, Pulsed Doppler, Ultrasonic IYN
System, Imaging, Pulsed Echo, Ultrasonic IYO
Transducer, Ultrasonic, Diagnostic ITX

Proprietary Names

MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2,MX2 BW Diagnostic Ultrasound System MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG Diagnostic Ultrasound System Emerus MX6,Emerus MX6 Exp, Anesus MX6,Anesus MX6 Exp, Crius MX6, Crius MX6 Exp Diagnostic Ultrasound System Emerus MX5,Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp Diagnostic Ultrasound System MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI Diagnostic Ultrasound System

Establishment Types

Manufacture Medical Device